Realizing the Return on Investment (ROI) of eRegulatory

Research sites are facing increased demands for a growing number of clinical research studies across therapeutic disciplines. As study volume has increased, so has the complexity of study protocols, remote access availability, and the number of data points collected throughout the study life cycle.

As a solution to these challenges, tools are emerging for the automation of study tasks, including Florence eBinders. How can a site manager prove that these tools provide a positive return on investment?

This blog examines six economic drivers paying back the cost of an eRegulatory and eSource platform so that centers can make an informed decision as they scale to advance cures. 

The findings show that oncology centers can capture nearly $20,000 of benefit per study. If you want to calculate your unique ROI, enter your details in our ROI calculator for quick results.

As study volume grows, the core issue is an increase in study volume and protocol complexity, which means a direct increase in task volume. However, site resources are not increasing at the same rate. 

Consequently, sites are being tasked with triple the work with the same amount of resources, staff, and budget.

The best research centers tackle this task burden with technology. Adopting tools, like eRegulatory and eSource, gives research teams the power to complete tasks more quickly and automate low-level work so that they have more time to enroll and care for their patients. 

While the above benefits seem intuitive, a seasoned research site should map out how such a tool helps in economic terms and build a return on investment (ROI) justification. 

We’ll explore exactly that here in a six-part framework:

  • Revenue from Increased Study Capacity
  • Cost Reduction from Streamlined Workflows
  • Revenue from Startup Bonuses
  • Risk Reduction through Compliance Assurance
  • Revenue from Document Management and Retention Fees
  • Cost Reduction during Remote Monitoring

Bonus Section: Additional Quantitative & Qualitative Return for eRegulatory Enabled Research Sites

How to calculate the financial ROI of eRegulatory and eSource? 

Using input from NCI centers, we detail how tools like Florence eBinders return 2 to 7x their cost each year via six economic benefits totaling nearly $20,000 in potential positive economic benefit per study. 

Per Study BenefitPer Study Financial Impact
Revenue from the capacity to run more studies$12,000
Cost reduction from streamlined workflows$3,600
Revenue from startup bonuses$2,000
Risk reduction through compliance assurance$2,000
Revenue from document management$1,000
Cost reduction during remote monitoring$400

The next sections will detail how the Florence team got to these six conclusions. Throughout, we’ll use the following simplistic assumptions for cancer research centers: 

  •   Center activity: 50 active studies per year
  •   Average study annual revenue: $100,000
  •   Median fully-loaded annual cost of study personnel $75,000

If you want to calculate your unique ROI of eRegulatory estimate, please visit our ROI calculator here,  You can input numbers specific to your site with an immediate output to determine if eRegulatory makes sense for your team.

Revenue from Increased Study Capacity

Although study demand is on the rise, many centers find it challenging to scale beyond the current study volume. Manual processes such as printing/scanning/filing, date tracking, project milestone management, and other tasks eat into bandwidth.

At Florence, we timed trained site personnel across tasks like document annotation, signatures and filing (Florence Healthcare Analysis, 2015). Electronic tools were found to speed these tasks by 40%. We estimate that these time savings affect about 30% overall study tasks, allowing your research team to take on (30% * 40%) = 12% more studies.

Net: A research center managing 50 studies can find capacity through software automation to take on six more with the same staff. At $100,000 per study, this drives over a half-million dollars in additional revenue.

Cost Reduction from Streamlined Workflows

Workflows are the heart of clinical trial document management. Review and signature processes for documentation like 1572s, financial disclosure, protocols, training, and serious adverse events absorb research staff time as they manage tasks like routing, form completion, annotation, and signatures. 

Secondary tasks in these workflows create additional waste. Repeat filing of similar documents from study to study, scanning and printing documents between digital and physical states, and maintaining paper logs and to-do lists.

eRegulatory workflows can eliminate the administrative burden on coordinators and investigators. Electronic systems also minimize the likelihood of document errors, drive consistency, and provide a new level of process oversight to clinical trial management.

Net: Electronic document routing editing and signatures remove an estimated person-day per month, per study— $300 per day each month equals approximately $3,600 a year per study.

Revenue from Startup Bonuses

Sponsors are keen to get drugs to market as early in their patent-window as possible. Even one day of study acceleration can mean millions in additional revenue for a given therapy. As an incentive to speed studies, sponsors are offering sites startup bonuses – payments received for hitting specified startup metrics such as site initiation and time to first patient. 

Sponsors offer startup bonuses exceeding $10,000 per protocol per site (Florence Healthcare Analysis, 2017).

eRegulatory platforms can help sites meet sponsors’ needs by reducing task time and accelerating the overall startup phase. Centers can capture more startup bonuses as a result.

Net: Electronic document routing editing and signatures remove an estimated person-day per month, per study— $300 per day each month equals approximately $3,600 a year per study.

It’s also important to note that since the time of this initial analysis, sponsors’ understanding of the benefits of eRegulatory has expanded. As a result, most sponsors actually prefer a site that has this technology in place and in most cases, will reimburse the site for its use. 

Risk Reduction through Compliance Assurance

Paper study binders are not only more time-consuming to manage but they pose compliance risk by lowering visibility into version control, sponsor communications, task completion, and protocol alignment. 

Moreover, paper management approaches allow missing and expired documents to go undetected until audit. Implementing an eRegulatory system reduces or eliminates those risks and drives the following compliance benefits:

  • Visual alerts and reporting provide compliance risk reduction between monitoring visits
  • Version control ensures the right document versions are available
  • Audit trails ensure the right processes were followed to deliver consistency across teams and studies

Net: A negative compliance finding puts future study opportunities at risk. A research center managing 50 studies may find their next $100,000 study to be in jeopardy. Spread across the total study count, this equates to a possible $2,000 risk per study.

Revenue from Document Management and Retention Fees

A portion of the cost of eRegulatory tools can be recuperated via cost pass-through. Specifically, the following line items can, in total, drive on average $1,000 in additional revenue per contract.

  •   Startup
  •   Document management
  •   Monitoring prep
  •   Document storage
  •   Regulatory upkeep
  •   Query response

Net: We estimate an additional $1,000 per industry study in document management and retention fees.

Cost Reduction During Remote Monitoring

In 2016, MAGI and Florence teamed to analyze the workload impact of remote monitoring. The study found that during the course of the average trial, approximately 2.5 visits were conducted remotely, and the prep time for each visit totaled 225 minutes—more than 2x the prep time required for an on-site monitoring visit. 

Remote monitoring visit prep time can be reduced to zero if access to digital regulatory and source is permitted through an eRegulatory tool. This recoups an estimated 9 hours of research teamwork per study per year.

Net: Nine hours of work per study per year, or about $400, can be saved by providing remote monitor access via an eBinder system.

If you want to calculate your unique ROI of eRegulatory estimate, please visit our ROI calculator here. You can input numbers specific to your site with an immediate output to determine if a tool makes sense for your team.

Bonus Section: Additional Quantitative & Qualitative Return for eRegulatory Enabled Research Sites

Let’s be clear here. While the above is impactful – and necessary – for a proper evaluation of your future eRegulatory investment, many benefits don’t fit in a traditional ROI model. These qualitative measures of value are expressed in ways unique to each research site, but equally impactful, especially in terms of reviewing your investment over time.

For example, a research site may ask questions like, how will this technology impact the culture of research at my organization? Will this technology expand our opportunities with experienced scientists and Principal Investigators? Will our research team benefit from adding more skills and, ultimately, be more satisfied at work?

Below are some examples of qualitative results we’ve witnessed from the over 10,000 Researchers using eBinders. Many of which have translated to the purely financial boost many organizations are seeking.